PAG · Class II · 21 CFR 878.3300

FDA Product Code PAG: Mesh, Surgical, Non-synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

Transvaginal Surgical Repair Of Female Stress Urinary Incontinence (sui) Due To Intrinsic Sphincter Deficiency (isd) And/or Urethral Hypermobility.

Leading manufacturers include C.R. Bard, Inc. and American Medical Systems, Inc..

9
Total
9
Cleared
57d
Avg days
1998
Since

FDA 510(k) Cleared Mesh, Surgical, Non-synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator Devices (Product Code PAG)

9 devices
1–9 of 9
Cleared Jun 17, 2005
AMS COLLAGEN DERMAL MATRIX
K050445
American Medical Systems, Inc.
General & Plastic Surgery · 115d
Cleared Nov 09, 2004
PELVILACE TRANSOBTURATOR BIOURETHRAL SUPPORT SYSTEM (PELVILACE TO SYSTEM)
K042949
C.R. Bard, Inc.
Gastroenterology & Urology · 14d
Cleared May 15, 2003
BARD INNERLACE BIOURETHRAL SUPPORT SYSTEM
K031295
C.R. Bard, Inc.
Gastroenterology & Urology · 22d

About Product Code PAG - Regulatory Context